First-in-human phase I trial with Lipigons lipid-lowering candidate Lipisense

Lipigon Pharmaceuticals AB ("Lipigon") has announced that their drug candidate Lipisense has been given to humans for the first time. The phase I clinical trial began on Tuesday.

This is an English translation of the Swedish original. In case of discrepancies, the Swedish original shall prevail.

Lipisense is a drug candidate developed to lower blood lipid triglycerides in patients with severely elevated levels by preventing the production of the protein ANGPTL4 in the liver. The primary purpose of the phase I study is to document the candidates safety, tolerability and pharmacokinetic profile while also evaluating efficacy on relevant biomarkers.

"It is a solemn and exhilarating feeling taking the most important step so far in the companys history. Today we start the first clinical study with Lipisense and give it to a human for the first time. We are anticipating the autumn because we have good hopes to receive the first value-adding results by then," says CEO Stefan K. Nilsson.

The preclinical studies of Lipisense were completed in 2021. Overall, they showed that Lipisense has a good safety profile. The drug candidate is now entering the clinical phase to be tested on humans.

"Normally, in a phase I study you can only expect to determine the dose and examine how well humans tolerate the drug candidate. But with Lipisense, we also believe that we will be able to see treatment effects, for example on blood lipids, which generally cannot be done until a later phase. This means major de-risking for the continued development", says Stefan K. Nilsson.

Preliminary summary data are expected during the first half of 2023.

The trial is a randomized, double-blind, placebo-controlled study of single ascending doses (SAD) and multiple ascending doses (MAD).

The SAD part includes 20 healthy study participants, divided into four groups, and the primary goal is to evaluate safety and tolerability after an injection of Lipisense or placebo. Four different dose levels of Lipisense will be tested to begin with. 

The MAD part includes 24 healthy study participants. The primary goal is to evaluate safety and tolerability after four doses of Lipisense at three different dose levels or placebo. The secondary objective is to assess the triglyceride-lowering effect.

 About Lipisense

The drug candidate is an RNA therapeutic that prevents the cells from producing the disease-promoting target protein ANGPTL4 by destroying the protein-coding RNA before the target protein has been formed. The target gene has a strong genetic association with plasma lipid levels and related diseases, such as type 2 diabetes and cardiovascular disease.

For more information, please contact:
Stefan K. Nilsson, CEO, Lipigon
Email: [email protected]
Phone: +46 705 78 17 68

About Lipigon

Lipigon develops novel therapeutics for patients with lipid metabolism disorders. The company is based on over 50 years of lipid research at Umeå University, Sweden. Lipigons initial focus is on orphan drugs and niche indications, but in the long term, the company will have the opportunity to target broader indications in the area, such as diabetes and cardiovascular disease. Lipigons pipeline includes four active projects: the RNA-drug Lipisense for treatment of hypertriglyceridemia; an RNA-drug for treatment of acute respiratory distress syndrome; a gene therapy treatment for the rare disease lipodystrophy, together with Combigene AB (publ); and a small molecule program for the treatment of dyslipidemia in collaboration with HitGen (Inc).

The companys share (LPGO) is traded on the Nasdaq First North Growth Market. Certified Adviser is G&W Fondkommission, email: [email protected], phone: +46 8 503 000 50.

Lipigons vd Stefan K. Nilsson ökar sitt innehav i bolaget

Lipigon Pharmaceuticals AB ("Lipigon") meddelar i dag att vd Stefan K. Nilsson har köpt aktier i Lipigon till ett sammanlagt värde om 44 499,60 kr till ett genomsnittspris om 1,20 kronor per aktie.


Lipigon publicerar delårsrapport för januari-september 2022

Lipigon Pharmaceuticals AB ("Lipigon") publicerar i dag sin delårsrapport för perioden 1 januari-30 september 2022. Delårsrapporten i sin helhet finns tillgänglig som bifogad fil samt på bolagets hemsida, www.lipigon.se. Nedan följer en kort sammanfattning.


Umeå på börsen

Lipigon Pharmaceuticals AB ("Lipigon") anordnar tillsammans med andra börsnoterade bolag från Umeå eventet "Umeå på börsen" den 17 november. Vd Stefan K. Nilsson kommer bland annat berätta om utvecklingen av Lipisense, bolagets läkemedelskandidat mot förhöjda triglycerider, och den pågående fas I-studien.


Stort intresse för Lipigon på konferenser och mässor

Lipigons första kliniska studie i full gång och parallellt pågår ett intensivt nätverkande på branschmässor och vetenskapliga konferenser både i Sverige och utomlands.  "Vi märker ett stort intresse för både oss och Lipisense just nu", säger vd Stefan k. Nilsson, nyss hemkommen från BIO-Europe i Tyskland.



Analysguiden: Lipigon presenterar lovande säkerhetsdata på patienter

Lipigon presenterade i förra veckan resultat från den pågående fas 1-studiens första del (SAD) med bolagets lipidsänkande läkemedelskandidat Lipisense. Studien uppnådde sitt viktigaste syfte där Lipisense tolererades väl hos patienterna och inga allvarliga biverkningar rapporterades. Trots denna goda nyhet sätter Analysguiden ett motiverat värde om 7,0 (11,6) kronor på Lipigon, vilket beror på fortsatt svagt börsklimat.


RÄTTELSE: Tidigare pressmeddelande angav felaktig tidstämpel i MAR-etiketten. Korrigerat pressmeddelande följer nedan:

"Lipigon rapporterar positiva top line-resultat från klinisk fas I-studie av Lipisense"

Lipigon Pharmaceuticals AB ("Lipigon") tillkännagav i dag positiva top line-resultat från SAD-delen i fas I-studien av prövningsläkemedel Lipisense i friska försökspersoner.


CORRECTION: In previous press release, the time stamp in the MAR label was incorrect. Corrected pressrelease follows below.

"Lipigon announces positive top-line data from phase I clinical study of Lipisense" 

Lipigon Pharmaceuticals AB ("Lipigon") today announced positive top-line results from a phase I SAD study of its investigational medicine Lipisense in healthy volunteers.
 


Lipigon rapporterar positiva top line-resultat från klinisk fas I-studie av Lipisense

Lipigon Pharmaceuticals AB ("Lipigon") tillkännagav i dag positiva top line-resultat från SAD-delen i fas I-studien av prövningsläkemedel Lipisense i friska försökspersoner.


Lipigon announces positive top-line data from phase I clinical study of Lipisense

Lipigon Pharmaceuticals AB ("Lipigon") today announced positive top-line results from a phase I SAD study of its investigational medicine Lipisense in healthy volunteers. 


Lipigon deltog i forskarmötet ELC i Tutzing, Tyskland

Lipigon Pharmaceuticals AB ("Lipigon") deltog i förra veckan i European Lipoprotein Clubs forskarmöte i Tutzing i Tyskland. Det var vd Stefan K. Nilssons femte och sista år i organisationskommittén.


Lipigons vd Stefan K. Nilsson ökar sitt innehav i bolaget

Lipigon Pharmaceuticals AB ("Lipigon") meddelar i dag att vd Stefan K. Nilsson har köpt aktier i Lipigon till ett sammanlagt värde om 67 800 kr till ett genomsnittspris om 1,905 kronor per aktie.


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